Actively Recruiting

Age: 18Years +
All Genders
ID03873064

Body Mass Index (BMI) and Quality of Life (QoL) in Patients with Solid Tumors

Led by University of Rome Tor Vergata · Updated on 2024-02-02

1380

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University of Rome Tor Vergata

Lead Sponsor

S

S.I.C.O.G. partners

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how body mass index (BMI) relates to health-related quality of life (HR-QoL) in patients with solid cancers, including breast, lung, colorectal, and others. The study aims to understand the complex relationship between low or high BMI and quality of life across different cancer stages, such as localized and metastatic, while considering factors like comorbidities, performance status, and treatments received. This prospective observational study will also explore how BMI and HR-QoL vary by tumor type and stage. Participants with a confirmed solid tumor diagnosis will be enrolled and asked to complete the EORTC QLQ-C30 questionnaire to assess quality of life. Data such as age, sex, weight, height, tumor site and stage, treatment, and other clinical details will be collected around the time of first referral. Follow-up assessments, including repeated questionnaires and clinical data, will occur every 4 to 6 months. The study will use these data to analyze associations between BMI and HR-QoL across different clinical settings. During the study, participants will provide information through questionnaires and clinical evaluations at baseline and regular intervals. Researchers will monitor various health indicators, performance status, and treatment types while maintaining a prospective database. The primary outcome is the relationship between BMI and HR-QoL scores measured by the EORTC QLQ-C30 questionnaire, with recruitment over 36 months and follow-up for 24 months after the last patient's enrollment. Safety and routine care continue as usual throughout the study.

CONDITIONS

Brief Title

Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of solid tumor
  • Age over 18 years
  • Signed informed consent
  • Life expectancy longer than 12 weeks
Not Eligible

You will not qualify if you...

  • Unable to complete the EORTC QLQ-C30 questionnaire
  • No confirmed diagnosis of solid tumor (e.g., patients in screening programs)
  • Presence of second malignancies that could affect study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 36 months recruitment plus 24 months follow-up after last patient enrollment

Participants are observed with periodic assessments including completion of the EORTC QLQ-C30 questionnaire and recording of anthropometric, demographic, clinical, and biochemical variables.

Visits every 4 to 6 months for reassessments

Trial Site Locations

Total: 1 location

1

Tor Vergata University Hospital

Rome, Italy, 00133

Actively Recruiting

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Research Team

V

Vincenzo Formica, MD, PhD

C

Cristiano Serci

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index.

Lisa Martin, Laura Birdsell, Neil Macdonald...

https://pubmed.ncbi.nlm.nih.gov/23530101

Associations between plasma insulin-like growth factor proteins and C-peptide and quality of life in patients with metastatic colorectal cancer.

Jeffrey A Meyerhardt, Jeffrey A Sloan, Daniel J Sargent...

https://pubmed.ncbi.nlm.nih.gov/15941948

Body-mass index and incidence of cancer: a systematic review and meta-analysis of prospective observational studies.

Andrew G Renehan, Margaret Tyson, Matthias Egger...

https://pubmed.ncbi.nlm.nih.gov/18280327

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

N K Aaronson, S Ahmedzai, B Bergman...

https://pubmed.ncbi.nlm.nih.gov/8433390